FDA (Devices) recall action 75502
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Synthes (USA) Products LLC is recalling 5,478 sterile 3.0 mm reaming rods because their peel pouches are delaminating.
Synthes (USA) Products LLC is recalling 2,157 sterile 2.5 mm reaming rods because their peel pouches are delaminating.
Synthes (USA) Products LLC is recalling 319 sterile 3.0 mm Guide Rods because their peel pouches are delaminating.
Synthes (USA) Products LLC is recalling 1,951 sterile 2.5 mm reaming rods because their peel pouches are delaminating.
Synthes (USA) Products LLC is recalling 139 units of 2.5 mm Guide Rods because their sterile peel pouches are delaminating.
Synthes (USA) Products LLC is recalling 887 sterile 3.0 mm reaming rods because their peel pouches are delaminating.
Synthes (USA) Products LLC is recalling 260 sterile 2.5 mm TI Calibrated Reaming Rods because their peel pouches are delaminating.
Synthes (USA) Products LLC is recalling 114 sterile extraction hooks because their peel pouches are delaminating, potentially compromising sterility.